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Clinical trialNCT00837759TerminatedPhase 2Interventional

Novel Therapy to Preserve Beta Cell Function in New Onset Type 1 Diabetes

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Enrollment7Autoimmune DiabetesDiabetes Mellitus Type 1
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Background: * Type 1 diabetes (T1D) occurs when the immune system attacks insulin-producing cells (beta cells) in the pancreas, resulting in their death. * Insulin injections currently are the best method for controlling blood sugar in individuals with T1D. However, animal studies have shown that the drugs sitagliptin and lansoprazole can help reverse beta cell damage or develop new beta cells. In addition, Diamyd has been shown to weaken the immune process that attacks pancreatic beta cells. Objectives: * To find out whether a combination treatment of sitagliptin, lansoprazole, and Diamyd will help maintain functioning beta cells and/or cause new beta cells to form. * To determine how the drug combination affects insulin doses and blood sugar control. * To determine whether the drug combination affects the immune response involved in T1D.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Balow James, MD

    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Study Director
    clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

DiamydGAD65InsulinLansoprazole →Sitagliptin →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
28 Feb 2009
Primary completion
31 Mar 2011
Completion
31 Mar 2011
Last update posted
3 Jan 2013
Registered enrollment
7
Registry id
NCT00837759
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.